A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain
- Registration Number
- NCT06074562
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to determine the safety and efficacy of LY3556050 versus placebo in participants with diabetic peripheral neuropathic pain (DPNP). The study will lasts approximately 24 weeks, across 3 study periods.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 410
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Have a history and current diagnosis of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) diagnosed for at least 6 months prior to screening.
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Have a stable glycemic control on stable diabetes treatment regimen for at least 90 days prior to day 1 with a hemoglobin A1c (HbA1c) ≤10 for T1D and HbA1c ≤11 for participants with T2D at time of screening.
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Have a history of daily peripheral neuropathic pain for at least 12 weeks based on participant report or medical history.
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Have a visual analog scale (VAS) pain value ≥40 and <95 during screening.
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Have presence of diabetic peripheral neuropathy of symmetrical nature and in lower extremities for ≥6 months and diagnosed by a score of Part B ≥3 on Michigan Neuropathy Screening Instrument
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Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
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Are willing to discontinue all medications taken for chronic pain conditions, except allowed concomitant pain medication permitted per protocol, for the duration of the study
- Have a body mass index ≤45 kilogram/square meter (kg/m²) (inclusive).
- Are men, or women able to abide by reproductive and contraceptive requirements.
- History of other potentially causative and/or confounding sources of pain that may impair self-assessment of pain due to DPNP.
- Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques.
- Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
- Are, in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.
- Have in the judgement of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
- Have a positive HIV test result at screening.
- Have a surgery planned during the study for any reason.
- Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3556050 Dose 1 LY3556050 Participants will receive LY3556050 orally. LY3556050 Dose 2 LY3556050 Participants will receive LY3556050 orally. Placebo Placebo Participants will receive placebo orally. LY3556050 Dose 3 LY3556050 Participants will receive LY3556050 orally.
- Primary Outcome Measures
Name Time Method Mean Change from Baseline for Average Pain Intensity Numeric Rating Scale (API-NRS) Baseline, Week 12
- Secondary Outcome Measures
Name Time Method Mean Change from Baseline for Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form (SF)8a Baseline, Week 12 Mean Change from Baseline for PROMIS Sleep Disturbance (SD)8b Baseline, Week 12 Mean Change from Baseline for Patient's Global Impression of Illness (PGI) Severity as Measured by PGI-Severity Baseline, Week 12 Mean Change from Baseline for Patient's Global Impression of Illness Status as Measured by PGI-Status Baseline, Week 12 Mean Change from Baseline for Patient's Global Impression of Change as Measured by PGI-Change Baseline, Week 12 Mean Change from Baseline for Neuropathy Total Symptom Score-6 (NTSS-6) Baseline, Week 12 Summary of Frequency, Timing and Amount of Rescue Medication Used During the Treatment Period Baseline to Week 12 Mean Change from Baseline for Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Baseline, Week 12 Mean Change from Baseline for Pain Interference with Sleep Baseline, Week 12 Mean Change from Baseline for PROMIS Physical Functioning Short Form (SF)10a Baseline, Week 12 Pharmacokinetics (PK): Plasma Concentration of LY3556050 Baseline to Week 12
Trial Locations
- Locations (68)
Medical Corporation Sato Medical clinic
🇯🇵Ootaku, Tokyo, Japan
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, Arizona, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Orange Grove Family Practice
🇺🇸Tucson, Arizona, United States
Preferred Research Partners
🇺🇸Little Rock, Arkansas, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Northern California Research - Sacramento
🇺🇸Sacramento, California, United States
CMR of Greater New Haven, LLC
🇺🇸Hamden, Connecticut, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Alliance for Multispecialty Research, LLC
🇺🇸Kansas City, Missouri, United States
Care Access - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
SKY Integrative Medical Center/SKYCRNG
🇺🇸Ridgeland, Mississippi, United States
StudyMetrix Research
🇺🇸Saint Peters, Missouri, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
UniMed Center
🇺🇸East Brunswick, New Jersey, United States
North Suffolk Neurology
🇺🇸Port Jefferson Station, New York, United States
Lucas Research - Hickory
🇺🇸Hickory, North Carolina, United States
Lucas Research, Inc
🇺🇸Morehead City, North Carolina, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Tristar Clinical Investigations
🇺🇸Philadelphia, Pennsylvania, United States
Suburban Research Associates
🇺🇸West Chester, Pennsylvania, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Velocity Clinical Research, Salt Lake City
🇺🇸West Jordan, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
DiaVize s.r.o.
🇨🇿Praha 4, Praha, Hlavní Mešto, Czechia
Vestra Clinics
🇨🇿European Union, Rychnov Nad Kněžnou, Czechia
Agentura Science Pro
🇨🇿Olomouc, Czechia
Matsuyama Shimin Hospital
🇯🇵Matsuyama, Ehime, Japan
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
EDUMED - Broumov
🇨🇿Broumov, Královéhradecký Kraj, Czechia
Diabet2 s.r.o., diabetologicka a interni ambulance
🇨🇿Praha, Praha 1, Czechia
Neurologická Ambulance - Forbeli
🇨🇿Praha, Praha 6, Czechia
FLEDIP - Na dlouhem lanu
🇨🇿Prague, Praha, Hlavní Mešto, Czechia
Kikuchi Naika Clinic
🇯🇵Maebashi, Gunma, Japan
Kure Medical Center
🇯🇵Kure, Hiroshima, Japan
Japanese Red Cross Asahikawa Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Yokohama Minoru Clinic
🇯🇵Yokohama, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
Sugiura Internal Medicine Clinic
🇯🇵Sokashi, Saitama, Japan
Suruga Clinic
🇯🇵Shizuoka-city, Shizuoka, Japan
Heishinkai Medical Group ToCROM Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Kunisaki Makoto Clinic
🇯🇵Fukuoka, Japan
Minamiosaka Hospital
🇯🇵Osaka, Japan
Plumeria DM Clinic
🇯🇵Shizuoka, Japan
Sejong General Hospital
🇰🇷Sosa-gu, Kyǒnggi-do, Korea, Republic of
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Taejǒn-Kwangyǒkshi, Korea, Republic of
Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
🇵🇱Wroclaw, Dolnośląskie, Poland
MICS Centrum Medyczne Torun
🇵🇱Torun, Kujawsko-pomorskie, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
🇵🇱Wyszkow, Mazowieckie, Poland
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
🇵🇱Krakow, Małopolskie, Poland
Zdrowie Osteo-Medic
🇵🇱Biaystok, Podlaskie, Poland
Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
🇵🇱Poznan, Wielkopolskie, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
🇵🇱Lodz, Łódzkie, Poland
Centrum Medyczne Pratia Katowice
🇵🇱Katowice, Śląskie, Poland
Pro Familia Altera
🇵🇱Katowice, Śląskie, Poland
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
🇵🇱Ruda Slaska, Śląskie, Poland